Overview
This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.
Eligibility
Inclusion Criteria:
- A body mass index (BMI) in the range 18.0-30.0
- Ability & willingness to provide written consent
Exclusion Criteria:
- Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
- History of bleeding disorders, coagulation variables or abnormal blood cell count.
- History of chronic illness.
- Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
- History of adverse reaction or allergy to any drug.
- Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
- History of drug or alcohol abuse
- Smoker or use of nicotine-containing products
- Blood pressure or heart rate at screening outside normal ranges.